CataractNCT00335400
Anesthetic and Dilating Gel for Cataract Surgery
A study testing Anesthetic Dilating Gel in people with Cataract, run by Queen's University at 1 site in Canada.
Trial summary
To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Anesthetic Dilating Gel
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- scheduled for first cataract surgery (i.e., first eye)
Who cannot join
- previous ocular surgery,
- pseudoexfoliation syndrome,
- diabetes,
- herpetic eye disease,
- posterior synechiae,
- previous uveitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation.
To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. As well, a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel, creating an "anesthetic dilating gel". Although success has been reported, there have been no studies to clearly demonstrate that the "anesthetic dilating gel" is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel. It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery. Stability (maintaining effectiveness over time) and contamination of the study gel will also be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia, while maintaining stability and sterility over time, hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery.
- Conditions
- Cataract
- Being tested
- Anesthetic Dilating Gel
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic Dilating GelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil dilation
Corneal anesthesia
Secondary outcomes (3)
Gel stability
Gel sterility
Patient comfort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startMar 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sherif R El-Defrawy, Queen's University
- Investigators
- Sherif El-Defrawy, MD PhD FRCSC, Principal investigator, Hotel Dieu Hospital, Kingston General Hospital, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335400
- Sponsor's protocol ID
- QUEENS-SRE-1
- Status last verified
- Jan 2016
- First submitted
- 8 Jun 2006
- Last updated
- 13 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation.
- ClinicalTrials.gov ID
- NCT00335400
- Acronym / sponsor ID
- QUEENS-SRE-1
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- May 2007 (actual)
- First posted
- 9 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. As well, a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel, creating an "anesthetic dilating gel". Although success has been reported, there have been no studies to clearly demonstrate that the "anesthetic dilating gel" is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel. It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery. Stability (maintaining effectiveness over time) and contamination of the study gel will also be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia, while maintaining stability and sterility over time, hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for first cataract surgery (i.e., first eye)
Key exclusion criteria (6 listed)
- previous ocular surgery,
- pseudoexfoliation syndrome,
- diabetes,
- herpetic eye disease,
- posterior synechiae,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthetic Dilating Gel | Drug | – |
Primary outcome
Pupil dilation
Corneal anesthesia
3 secondary outcomes
Gel stability
Gel sterility
Patient comfort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif El-Defrawy, MD PhD FRCSC principal investigator
Hotel Dieu Hospital, Kingston General Hospital, Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthetic Dilating Gel in people with Cataract, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil dilation. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.